Efficacy and safety of Wuling capsule, a single herbal formula, in Chinese subjects with insomnia: a multicenter, randomized, double-blind, placebo-controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Wuling Capsule is a single herbal formula from mycelia of precious Xylaria nigripes (Kl.) Sacc and its pharmacological function have a tranquilizing effect on the central nervous system. The aim of the study to evaluate the efficacy and safety of Wuling capsule in treatment of insomnia. MATERIALS AND METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled study. The participants received either placebo (n=92) or Wuling capsule (n=94) for 4 weeks and a follow-up period for 2 weeks. RESULTS: Compared between pre-treatment and post-treatment, the global Pittsburgh sleep quality index (PSQI) scores in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there was no significant difference between Wuling capsule group and placebo group (P>0.05). Scores of clinical global impressions scale (CGI-I) at each week in Wuling capsule group was similar to those in placebo group (P>0.05). Compared between pre-treatment and post-treatment, scores of the four components of world health organization on quality of life brief scale (WHOQOL-BREF) in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there were no difference between the two groups (P>0.05). The rate of adverse events was 10.10% in Wuling group, and 6.73% in placebo group (P>0.05). CONCLUSIONS: Wuling capsule can improve insomnia when compared with pre-treatment for 4 weeks and be a well tolerated by all the patients at the 6 weeks of study period. However, there are no significant in the results of the variables tested when compared with placebo control. Further additional rigorous randomized clinical trials are still required.

[Contrast study of acupuncture anesthesia and local anesthesia: their effects on the blood pressure and the heart rate in chronic rhinitis patients accompanied inferior turbinate hypertrophy in low temperature radiofrequency ablation].

OBJECTIVE: To compare the effects of acupuncture anesthesia (AA) and local anesthesia (LA) on the blood pressure (BP) and the heart rate (HR) in chronic rhinitis patients accompanied inferior turbinate hypertrophy in low temperature radiofrequency ablation (RFA). METHODS: Totally 61 chronic rhinitis patients accompanied inferior turbinate hypertrophy were randomly assigned to the AA group (31 cases) and the control group (30 cases). All patients received RFA respectively under AA and RA. Their heart rate (HR), systolic pressure (SP), diastolic pressure (DP), and mean pressure (MP) were recorded and compared at 10 minutes after their entry into the operating room, immediately before surgery, intraoperation, and 5 min after operation. RESULTS: When compared with the control group at the same time points, the SP, DP, MP, and HR all decreased at intraoperation and 5 min after operation in the AA group. There was statistical difference in the SP on the right side at the 2nd melting point and the HR on the left side at the 2nd melting point between the two groups (P < 0.05). Compared with the same group at 10 min after entry into the operating room, the SP on the right side at the 1st melting point, the SP, DP, and MP on the right side at the 2nd melting point, the SP, DP, and MP on the left side at the 1st melting point, and the SP on the left side at the 2nd melting point all obviously increased with statistical difference (P < 0.05, P < 0.01). When compared with the same group at 10 min after entry into the operating room and immediately before surgery, there was no statistical difference in the SP, DP, MP, or HR of the AA group at intraoperation and 5 min after operation (P > 0.05). When compared with the same group at 10 min after entry into the operating room and immediately before surgery, there was no statistical difference in HR of the control group at intraoperation and 5 min after operation (P > 0.05). CONCLUSION: Patients undergoing AA had less fluctuation of the BP and the HR, indicating AA had better analgesic effects.

[Randomized controlled study on electroacupuncture compound anesthesia in radiofrequency ablation for hypertrophic inferior turbinate].

OBJECTIVE: To explore the feasibility of electroacupuncture compound anesthesia in radiofrequency ablation for hypertrophic inferior turbinate. METHODS: The patients confirmed to the enrolled criteria were randomly divided into an observation group (n = 31) and a control group (n = 30). The observation group was treated with electroacupuncture at Sibai (ST 2), Xiaguan (ST 7), Hegu (LI 4) and Zhigou (TE 6) on the left side and routine local anesthesia on the right side. The control group was treated with routine local anesthesia on the both side. The feelings of pain, circulatory index and operation effect were observed and compared. RESULTS: During radiofrequency ablation, the pain grade of two measurements on the left side and the 2nd measurement on the right in the observation group were all lower than those in the control group (all P<0.05). In the observation group, the pain grades on the left side were lower than that on the right side (P<0.05), and the systolic blood pressure and the heart rate were lower than that in the control group when undergoing the 2nd radiofrequency ablation on the right side and on the left side, respectively (both P<0.05). There was no significant difference in operation effect between the two groups. CONCLUSION: Electroacupuncture compound anesthesia can meet the analgesia requirement of radiofrequency ablation for treatment of hypertrophic inferior turbinate, and would be helpful to prevent cyclic fluctuation during the operation at the same time.